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BR-513_PIL.pdf
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BR-513
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Hepatitis A Vaccine (Inactivated, Adsorbed)
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Avaxim 80
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Formulation:
Each dose (0.5 mL) contains:
Hepatitis A virus, GBM Strain* (inactivated)**
*Cultured on MRC-5 human diploid cells
80 ELISA units***
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Suspension for Injection (IM)
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Prescription Drug (RX)
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Type I pre-filled glass syringe with heat marker x 0.5 mL (Box)
Type I pre-filled glass syringe x 0.5 mL (Box of 1's)
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Vaccines
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Sanofi Pasteur
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France
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N/A
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Sanofi Pasteur, Inc.
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Zuellig Pharma Corporation.
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Initial (Variation)
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28 May 2025
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28 May 2030
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| View |
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BR-514
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Rabies Vaccine (Inactivated) (Wistar Strain Rabies)
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Verorab
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2.5 IU/ 0.5 mL
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Powder for Suspension for Injection
(ID/IM)
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Prescription Drug (RX)
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: One box contains: 5 vials + 5 ampoules of 0.5 mL 0.4%
Sodium chloride (as diluent).
.
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-
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Sanofi Pasteur SA
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France
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N/A
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Sanofi Pasteur, Inc.
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Zuellig Pharma Corporation
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Renewal
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03 July 2023
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10 December 2027
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| View |
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BR-515
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Rabies Vaccine (Inactivated)
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Chirorab
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2.5 IU/mL
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Lyophilized Powder for Injection (ID/IM)
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Prescription Drug (RX)
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3 mL USP Type I clear and colorless glass vial with bromobutyl rubber stopper and aluminum crimp cap. with red flip-off seal + 1 mL ampoule (Sterile Water for Injection as diluent) + 2 mL injection syringe, luer nozzle with a separate needle in a blister (Box of 1's)
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Vaccines
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Chiron Behring Vaccines Pvt., Ltd.
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India
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N/A
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Glovax Biotech Corp.
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Glovax Biotech Corp.
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Renewal
|
06 July 2025
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25 January 2031
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| View |
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BR-518
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Diphtheria, Tetanus, Pertussis (Acellular Component), And Poliomyelitis (Inactivated) Vaccine (Adsorbed)
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Vaxigrip Tetra
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MULTICOMPONENT/0.5ML
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Suspension For Injection (IM)
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Prescription Drug (RX)
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0.5 mL Pre-filled glass syringe with needle (Box of 1's and 10's). Single dose.
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Vaccine
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Sanofi Pasteur
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France
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N/A
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Sanofi Pasteur, Inc.
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Zuellig Pharma Corporation
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Initial (Variation)
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10 November 2022
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10 November 2027
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| View |
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BR-525
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Tetanus Antitoxin Refined
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Antitet 1500 Iu
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1500 IU 0.7mL
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Solution For Injection
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Prescription Drug (RX)
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0.7mL Clear Glass Ampoule (Box of 10's)
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Antisera
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Jiangxi Institute of Biological Products
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China
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2 World Traders Inc.
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2 World Traders Inc.
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Automatic Renewal
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08 July 2023
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09 June 2028
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| View |
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BR-526
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Tetanus Antitoxin Refined
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Antitet 5000 Iu
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5000 IU/2mL
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Solution For Injection
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Prescription Drug (RX)
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2 mL Clear Glass Ampoule (Box of 10's)
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Antisera
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Jiangxi Institute of Biological Products
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China
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2 World Traders Inc.
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2 World Traders Inc.
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Automatic Renewal
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08 July 2023
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09 June 2028
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| View |
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BR-527
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Tetanus Antitoxin Refined
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Antitet 3000 Iu
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3000 I.U./0.95%
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Solution For Injection
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Prescription Drug (RX)
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0.95mL Clear Glass Ampoule (Box of 10's)
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Antisera
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Jiangxi Institute of Biological Products
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China
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2 World Traders Inc.
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2 World Traders Inc.
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Automatic Renewal
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08 July 2023
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19 June 2028
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| View |
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BR-531
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Human Albumin
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Albutein
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0.05
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Solution for Injection for Infusion (IV)
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Prescription Drug (RX)
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250 mL or 500 mL USP Type II glass vial with gray chlorobutyl rubber stopper and aluminum overseal with willow green-color plastic flip-off seal (Box of 1's).
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-
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Grifols Biologicals LLC
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U.S.A
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N/A
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GB Distributors, Inc.
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N/A
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Renewal
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28 April 2023
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25 May 2027
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| View |
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BR-523
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Diphtheria, Tetanus, Pertussis (Acellular Poliomyelitis (Inactivated) Vaccine and Haemophilus influenzae Type B Conjugate Vaccine (Adsorbed)
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Pentaxim
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After reconstitution, each dose (0.5 mL) contains:
Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigen
Pertussis toxoid
Filamentous hemagglutinin Poliovirus (Inactivated)
>30 IU
>40 IU
Polysaccharide influenzae Type B Conjugated to tetanus protein
of
Haemophilus 10 mcg
18-30 mcg
25 mcg
25 mcg
Type I poliomyelitis virus (inactivated)
40 D antigen
units
Type II poliomyelitis virus (inactivated)
8 D antigen units
Type III poliomyelitis virus (inactivated)
32
D' antigen
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Suspension and Powder for Suspension for Injection (IM)
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Prescription Drug (RX)
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Type I pre-filled glass syringe with 2 separate needles + Type I glass vial (Box of 1's and Box of 10's)
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-
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Sanofi Pasteur, Inc.
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France
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N/A
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Sanofi Pasteur, Inc
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Zuellig Pharma Corporation
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Renewal
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14 September 2023
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21 August 2028
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| View |
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BR-536
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Human Plasma Coagulation Factor VIII
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Emoclot
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500 IU
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Lyophilized Powder for Injection (IV)
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Prescription Drug (RX)
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Type I glass vial + 10 mL diluent (Water for Injection) in a box
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-
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Kedrion S.p.A
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Italy
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N/A
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New Marketlink Pharmaceutical Corporation
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Metro Drug Inc.
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Initial (Variation)
|
06 October 2022
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06 October 2027
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| View |
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BR-539
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Human Coagulation Factor IX
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Aimafix
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500IU
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Lyophilized Powder For Injection
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Prescription Drug (RX)
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Type 1 clear and colourless glass vial + 10mL diluent (Water for Injection) with 1 infusion set
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Plasma Fraction for Specific Use
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Kedrion S.P.A
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Italy
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New Marketlink Pharmaceutical Corporation
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Metro Drug Inc.
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Renewal
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04 April 2019
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14 January 2029
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| View |
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BR-540
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Botulinum Toxin Type A
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Dysport
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500 Units
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Lyophilized Powder for Injection (IM/SC)
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Prescription Drug (RX)
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Clear and colorless glass vial with rubber stopper, aluminum seal and flip-off cap (Box of 1's)
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500 U Lyophilized Powder for Injection (IM/SC)
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IPSEN Biopharm Ltd.
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United Kingdom
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Zuellig Pharma Corp.
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Zuellig Pharma Corp.
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Renewal
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01 August 2023
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14 January 2029
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| View |
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BR-567
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HEPATITIS B VACCINE ( rDNA )
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GENVAC-B
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10mcg/0.5mL
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Suspension For Injection(IM)
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Prescription Drug (RX)
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Single dose. Glass vial x 0.5 mL (Box of 50's)
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Vaccines
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Serum Institute of India Pvt. Ltd.
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India
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Genpharm, Inc.
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Genpharm, Inc.
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Renewal
|
07 January 2025
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17 January 2030
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| View |
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BR-568
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HEPATITIS B VACCINE ( rDNA )
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Unbranded
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20 mcg/mL
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Suspension for Injection(IM) (Multidose) (Adult)
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Prescription Drug (RX)
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Glass vial x 10 mL (Box of 50's)
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Hepatitis Vaccine
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Serum Institue of India Ltd.
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India
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N/A
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Genpharm Inc.
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Genpharm Inc.
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Renewal
|
17 January 2025
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17 January 2030
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| View |
BR-572_PI_01.pdf
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BR-572
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Bacillus Calmette-Guerin (BCG) Vaccine
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None
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2x105 and 8x105 C.F.U. per 0.1 mL
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Powder
for Suspension for Injection (ID)
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Prescription Drug (RX)
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Amber glass vial with blue flip-off cap x 1 mL + 0.9% w/v Sodium chloride as diluent in clear and colorless glass ampoule x 1 mL (Box of 1's and 50's)
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Vaccine
|
Serum Institute of India Private Limited
|
India
|
N/A
|
Genpharm Inc.
|
Genpharm Inc.
|
Initial (Variation)
|
05 May 2025
|
05 May 2030
|
| View |
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BR-574
|
HEPATITIS B VACCINE ( rDNA )
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GENVAC-B
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20mcg/mL
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Suspension For Injection (IM) Single Dose (Adult)
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Prescription Drug (RX)
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Glass vial x 10 mL (Box of 50's)
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VACCINES
|
Serum Institue of India Pvt. Ltd.
|
India
|
|
Genpharm Inc.
|
Genpharm Inc.
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Renewal
|
16 April 2025
|
11 May 2031
|
| View |
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BR-589
|
Hepatitis B Vaccine (rDNA)
|
Unbranded
|
10mcg/0.5mL
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Suspension for Injection (IM) (Pediatric)
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Prescription Drug (RX)
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5 mL Clear Glass Vial (Box of 50's)
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Vaccine
|
Serum Institute of India Private Limited
|
India
|
|
Genpharm, Inc.
|
|
Renewal
|
06 July 2025
|
05 October 2030
|
| View |
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BR-591
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Tuberculin Purified Protein Derivative
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None
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2TU/0.1mL
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Solution For Injection (Id)
|
Prescription Drug (RX)
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1ML, 1.5ML, 5ML, 10ML VIAL PER BOX
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Diagnostic Agent
|
Arkray Healthcare Pvt. Ltd.
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India
|
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National Biotec Medical Supply Co., Ltd
|
L. Meyerf Pharma Inc
|
Renewal (Variation)
|
02 August 2022
|
28 October 2027
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| View |
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BR-596
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Bacillus Calmette-Guerin (BCG) Vaccine
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None
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250 mcg
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Freeze-dried Powder for Intradermal Injection
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Prescription Drug (RX)
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In a box consisting of 1 plastic tray containing 0.5 mL- capacity clear and colorless glass ampoule x 5's and 1 plastic tray containing 0.5 mL-net content of Sterile Water for Injection in an ampoule x 5's
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Immunostimulant
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Chengdu Institute of Biological Products
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China
|
N/A
|
National Biotec Medical Supply Co. Ltd.
|
National Biotec Medical Supply Co. Ltd.
|
Renewal
|
24 August 2023
|
10 March 2028
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| View |
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BR-599
|
Human Tetanus Immunoglobulin
|
Tetagam P
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250 I.U. (100 mg to 170 mg)/mL
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Solution For Injection (I.M.)
|
Prescription Drug (RX)
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1 mL pre-filled syringe with 1 separate safety glide
needle x 216 12" per box
|
-
|
CSL Behring GmbH
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Germany
|
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Zuellig Pharma Corporation
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Zuellig Pharma Corporation
|
-
|
28 October 2021
|
12 September 2026
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